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Interventions for improving sleep quality in people with chronic kidney disease.

Background: Sleep disorders are commonly experienced by people with chronic kidney disease (CKD). Several approaches for improving sleep quality are used in clinical practice including relaxation techniques, exercise, acupressure, and medication. Objectives: To assess the effectiveness and associated adverse events of interventions designed to improve sleep quality among adults and children with CKD including people with end-stage kidney disease (ESKD) treated with dialysis or kidney transplantation. Search methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 8 October 2018 with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. Selection criteria: We included randomised controlled trials (RCTs) or quasi-randomised RCTs of any intervention in which investigators reported effects on sleep quality. Two authors independently screened titles and abstracts of identified records. Data collection and analysis: Two review authors independently extracted data and assessed the risk of bias for included studies. The primary outcomes were sleep quality, sleep onset latency, sleep duration, sleep interruption, and sleep efficiency. Risks of bias were assessed using the Cochrane tool. Evidence certainty was assessed using the GRADE approach. We calculated treatment estimates as risk ratios (RR) for dichotomous outcomes or mean difference (MD) or standardised MD (SMD) for continuous outcomes to account for heterogeneity in measures of sleep quality. Main results: Sixty-seven studies involving 3427 participants met the eligibility criteria. Thirty-six studies involving 2239 participants were included in meta-analyses. Follow-up for clinical outcomes ranged between 0.3 and 52.8 weeks (median 5 weeks). Interventions included relaxation techniques, exercise, acupressure, cognitive-behavioural therapy (CBT), educational interventions, benzodiazepine treatment, dopaminergic agonists, telephone support, melatonin, reflexology, light therapy, different forms of peritoneal dialysis, music, aromatherapy, and massage. Incomplete reporting of key methodological details resulted in uncertain risk of bias in many studies. In very low certainty evidence relaxation techniques had uncertain effects on sleep quality and duration, health-related quality of life (HRQoL), depression, anxiety, and fatigue. Studies were not designed to evaluate the effects of relaxation on sleep latency or hospitalisation. Exercise had uncertain effects on sleep quality (SMD -1.10, 95% CI -2.26 to 0.05; I2 = 90%; 5 studies, 165 participants; very low certainty evidence). Exercise probably decreased depression (MD -9.05, 95% CI -13.72 to -4.39; I2 = 0%; 2 studies, 46 participants; moderate certainty evidence) and fatigue (SMD -0.68, 95% CI -1.07 to -0.29; I2 = 0%; 2 studies, 107 participants; moderate certainty evidence). Compared with no acupressure, acupressure had uncertain effects on sleep quality (Pittsburgh Sleep Quality Index (PSQI) scale 0 - 21) (MD -1.27, 95% CI -2.13 to -0.40; I2 = 89%; 6 studies, 367 participants: very low certainty evidence). Acupressure probably slightly improved sleep latency (scale 0 - 3) (MD -0.59, 95% CI -0.92 to -0.27; I2 = 0%; 3 studies, 173 participants; moderate certainty evidence) and sleep time (scale 0 - 3) (MD -0.60, 95% CI -1.12 to -0.09; I2 = 68%; 3 studies, 173 participants; moderate certainty evidence), although effects on sleep disturbance were uncertain as the evidence certainty was very low (scale 0 - 3) (MD -0.49, 95% CI -1.16 to 0.19; I2 = 97%). In moderate certainty evidence, acupressure probably decrease fatigue (MD -1.07, 95% CI -1.67 to -0.48; I2 = 0%; 2 studies, 137 participants). Acupressure had uncertain effects on depression (MD -3.65, 95% CI -7.63 to 0.33; I2 = 27%; 2 studies, 137 participants; very low certainty evidence) while studies were not designed to evaluate the effect of acupressure on HRQoL, anxiety, or hospitalisation. It was uncertain whether acupressure compared with sham acupressure improved sleep quality (PSQI scale 0 to 21) because the certainty of the evidence was very low (MD -2.25, 95% CI -6.33 to 1.82; I2 = 96%; 2 studies, 129 participants), but total sleep time may have been improved (SMD -0.34, 95% CI -0.73 to 0.04; I2 = 0%; 2 studies, 107 participants; low certainty evidence). 2 =2 =There were no studies designed to directly examine and/or correlate efficacy of any interventions aimed at improving sleep that may have been attempted for the spectrum of sleep disordered breathing. No studies reported treatment effects for children. Adverse effects of therapies were very uncertain. Authors' conclusions: The evidence base for improving sleep quality and related outcomes for adults and children with CKD is sparse. Relaxation techniques and exercise had uncertain effects on sleep outcomes. Acupressure may improve sleep latency and duration, although these findings are based on few studies. The effects of acupressure were not confirmed in studies in which sham acupressure was used as the control. Given the very low certainly evidence, future research will very likely change the evidence base. Based on the importance of symptom management to patients, caregivers and clinicians, future studies of sleep interventions among people with CKD should be a priority.

The Cochrane database of systematic reviews · systematic review · 45 citationsread the source →

Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial.

Background: For men with localised prostate cancer, surgery provides a survival benefit compared with watchful waiting. Treatments are associated with morbidity. Results for functional outcome and quality of life are rarely reported beyond 10 years and are lacking from randomised settings. We report results for quality of life for men in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) after a median follow-up of more than 12 years. Methods: All living Swedish and Finnish men (400 of 695) randomly assigned to radical prostatectomy or watchful waiting in SPCG-4 from 1989 to 1999 were included in our analysis. An additional 281 men were included in a population-based control group matched for region and age. Physical symptoms, symptom-induced stress, and self-assessed quality of life were evaluated with a study-specific questionnaire. Longitudinal data were available for 166 Swedish men who had answered quality-of-life questionnaires at an earlier timepoint. Findings: 182 (88%) of 208 men in the radical prostatectomy group, 167 (87%) of 192 men in the watchful-waiting group, and 214 (76%) of 281 men in the population-based control group answered the questionnaire. Men in SPCG-4 had a median follow-up of 12·2 years (range 7-17) and a median age of 77·0 years (range 61-88). High self-assessed quality of life was reported by 62 (35%) of 179 men allocated radical prostatectomy, 55 (34%) of 160 men assigned to watchful waiting, and 93 (45%) of 208 men in the control group. Anxiety was higher in the SPCG-4 groups (77 [43%] of 178 and 69 [43%] of 161 men) than in the control group (68 [33%] of 208 men; relative risk 1·42, 95% CI 1·07-1·88). Prevalence of erectile dysfunction was 84% (146 of 173 men) in the radical prostatectomy group, 80% (122 of 153) in the watchful-waiting group, and 46% (95 of 208) in the control group and prevalence of urinary leakage was 41% (71 of 173), 11% (18 of 164), and 3% (six of 209), respectively. Distress caused by these symptoms was reported significantly more often by men allocated radical prostatectomy than by men assigned to watchful waiting. In a longitudinal analysis of men in SPCG-4 who provided information at two follow-up points 9 years apart, 38 (45%) of 85 men allocated radical prostatectomy and 48 (60%) of 80 men allocated watchful waiting reported an increase in number of physical symptoms; 50 (61%) of 82 and 47 (64%) of 74 men, respectively, reported a reduction in quality of life. Interpretation: For men in SPCG-4, negative side-effects were common and added more stress than was reported in the control population. In the radical prostatectomy group, erectile dysfunction and urinary leakage were often consequences of surgery. In the watchful-waiting group, side-effects can be caused by tumour progression. The number and severity of side-effects changes over time at a higher rate than is caused by normal ageing and a loss of sexual ability is a persistent psychological problem for both interventions. An understanding of the patterns of side-effects and time dimension of their occurrence for each treatment is important for full patient information. Funding: US National Institutes of Health; Swedish Cancer Society; Foundation in Memory of Johanna Hagstrand and Sigfrid Linnér.

The Lancet. Oncology · randomised controlled trial · 277 citationsread the source →

Effect of Cognitive Bias Modification on Early Relapse Among Adults Undergoing Inpatient Alcohol Withdrawal Treatment: A Randomized Clinical Trial.

Importance: More than half of patients with alcohol use disorder who receive inpatient withdrawal treatment relapse within weeks of discharge, hampering subsequent uptake and effectiveness of psychological and pharmacologic interventions. Cognitive bias modification (CBM) improves outcomes after alcohol rehabilitation, but the efficacy of delivering CBM during withdrawal treatment has not yet been established. Objective: To test the hypothesis that CBM would increase the likelihood of abstaining from alcohol during the 2 weeks following discharge from inpatient withdrawal treatment. Design, setting, and participants: In a randomized clinical trial, 950 patients in 4 inpatient withdrawal units in Melbourne, Australia, were screened for eligibility between June 4, 2017, and July 14, 2019, to receive CBM or sham treatment. Patients with moderate or severe alcohol use disorder aged 18 to 65 years who had no neurologic illness or traumatic brain injury were eligible. Two-week follow-up, conducted by researchers blinded to the participant's condition, was the primary end point. Both per-protocol and intention-to-treat analysis were conducted. Interventions: Randomized to 4 consecutive daily sessions of CBM designed to reduce alcohol approach bias or sham training not designed to modify approach bias. Main outcomes and measures: Primary outcome was abstinence assessed using a timeline followback interview. Participants were classified as abstinent (no alcohol use in the first 14 days following discharge) or relapsed (any alcohol use during the first 14 days following discharge or lost to follow-up). Results: Of the 950 patients screened for eligibility, 338 did not meet inclusion criteria, 108 were discharged before being approached, and 192 refused. Of the 312 patients who consented (referred sample), 12 withdrew before being randomized. In the final population of 300 randomized patients (CBM, n = 147; sham, n = 153), 248 completed the intervention and 272 completed the follow-up. Of the 300 participants (173 [57.7%] men; mean [SD] age, 43.47 [10.43] years), 7 patients (3 controls, 4 CBM) withdrew after finding the training uncomfortable. Abstinence rates were 42.5% (95% CI, 34.3%-50.6%) in controls and 54.4% (95% CI, 46.0%-62.8%) in CBM participants, yielding an 11.9% (95% CI, 0.04%-23.8%; P = .04) difference in abstinence rates. In a per-protocol analysis including only those who completed 4 sessions of training and the follow-up, the difference in abstinence rate between groups was 17.0% (95% CI, 3.8%-30.2%; P = .008). Conclusions and relevance: The findings of this clinical trial support the efficacy of CBM for treatment of alcohol use disorder. Being safe and easy to implement, requiring only a computer and joystick, and needing no specialist staff/training, CBM could be routinely offered as an adjunctive intervention during withdrawal treatment to optimize outcomes. Trial registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617001241325.

JAMA psychiatry · randomised controlled trial · 67 citationsread the source →

Five-year follow-up of harms and benefits of behavioral infant sleep intervention: randomized trial.

Background and objectives: Randomized trials have demonstrated the short- to medium-term effectiveness of behavioral infant sleep interventions. However, concerns persist that they may harm children's emotional development and subsequent mental health. This study aimed to determine long-term harms and/or benefits of an infant behavioral sleep program at age 6 years on (1) child, (2) child-parent, and (3) maternal outcomes. Methods: Three hundred twenty-six children (173 intervention) with parent-reported sleep problems at age 7 months were selected from a population sample of 692 infants recruited from well-child centers. The study was a 5-year follow-up of a population-based cluster-randomized trial. Allocation was concealed and researchers (but not parents) were blinded to group allocation. Behavioral techniques were delivered over 1 to 3 individual nurse consultations at infant age 8 to 10 months, versus usual care. The main outcomes measured were (1) child mental health, sleep, psychosocial functioning, stress regulation; (2) child-parent relationship; and (3) maternal mental health and parenting styles. Results: Two hundred twenty-five families (69%) participated. There was no evidence of differences between intervention and control families for any outcome, including (1) children's emotional (P = .8) and conduct behavior scores (P = .6), sleep problems (9% vs 7%, P = .2), sleep habits score (P = .4), parent- (P = .7) and child-reported (P = .8) psychosocial functioning, chronic stress (29% vs 22%, P = .4); (2) child-parent closeness (P = .1) and conflict (P = .4), global relationship (P = .9), disinhibited attachment (P = .3); and (3) parent depression, anxiety, and stress scores (P = .9) or authoritative parenting (63% vs 59%, P = .5). Conclusions: Behavioral sleep techniques have no marked long-lasting effects (positive or negative). Parents and health professionals can confidently use these techniques to reduce the short- to medium-term burden of infant sleep problems and maternal depression.

Pediatrics · randomised controlled trial · 69 citationsread the source →

Factors associated with risk of developmental delay in preschool children in a setting with high rates of malnutrition: a cross-sectional analysis of data from the IHOPE study, Madagascar.

Background: 50% of Malagasy children have moderate to severe stunting. In 2016, a new 10 year National Nutrition Action Plan (PNAN III) was initiated to help address stunting and developmental delay. We report factors associated with risk of developmental delay in 3 and 4 year olds in the rural district of Ifanadiana in southeastern Madagascar in 2016. Methods: The data are from a cross-sectional analysis of the 2016 wave of IHOPE panel data (a population-representative cohort study begun in 2014). We interviewed women ages 15-49 using the MICS Early Child Development Indicator (ECDI) module, which includes questions for physical, socio-emotional, learning and literacy/numeracy domains. We analyzed ECDI data using standardized z scores for relative relationships for 2 outcomes: at-risk-for-delay vs. an international standard, and lower-development-than-peers if ECDI z scores were > 1 standard deviation below study mean. Covariates included demographics, adult involvement, household environment, and selected child health factors. Variables significant at alpha of 0.1 were included a multivariable model; final models used backward stepwise regression, clustered at the sampling level. Results: Of 432 children ages 3 and 4 years, 173 (40%) were at risk for delay compared to international norms and 68 children (16.0%) had lower-development than peers. This was driven mostly by the literacy/numeracy domain, with only 7% of children considered developmentally on track in that domain. 50.5% of children had moderate to severe stunting. 76 (17.6%) had > = 4 stimulation activities in past 3 days. Greater paternal engagement (OR 1.5 (1.09, 2.07)) was associated with increased delay vs. international norms. Adolescent motherhood (OR. 4.09 (1.40, 11.87)) decreased children's development vs. peers. Engagement from a non-parental adult reduced odds of delay for both outcomes (OR (95%CI = 0.76 (0.63, 0.91) & 0.27 (0.15, 0 48) respectively). Stunting was not associated with delay risk (1.36 (0.85, 2.15) or low development (0.92 (0.48, 1.78)) when controlling for other factors. Conclusions: In this setting of high child malnutrition, stunting is not independently associated with developmental risk. A low proportion of children receive developmentally supportive stimulation from adults, but non-parent adults provide more stimulation in general than either mother or father. Stimulation from non-parent adults is associated with lower odds of delay.

BMC pediatrics · 16 citationsread the source →

A psychosocial intervention for stroke survivors and carers: 12-month outcomes of a randomized controlled trial.

Background and Purpose: Stroke can have a devastating impact on the mental and physical health of stroke survivors and their carers. We aimed to evaluate the effectiveness of a novel psychosocial intervention designed to improve health outcomes in both groups. Methods: We conducted a randomized controlled trial of a personalized psychosocial intervention (eight 1-hour weekly sessions plus one booster) compared to usual care for adult stroke survivors and carers. Participants recruited from hospital services and community referrals completed questionnaires at baseline, 3, 6, and 12 months. Primary outcomes were quality of life and self-efficacy; secondary outcomes were depressive and anxiety symptoms, coping, illness perception, work and social adjustment, carer strain, and carer satisfaction. Mixed-effect model repeated measures analysis between groups and across time was conducted. Results: Of the 173 participants recruited (89 stroke survivors; 84 carers), a total of 137 participants - 73 stroke survivors (intervention n = 42; usual care n = 31) and 64 carers (intervention n = 35; usual care n = 29) - underwent analysis up to 12 months. No statistically significant differences were found in the primary outcomes between groups over time, though a significant improvement in carer satisfaction was found at 6 months in the intervention group compared to the usual care group. Conclusion: A personalized psychosocial intervention resulted in a significant improvement in carer satisfaction at 6 months but in no other outcomes. A lack of available services and barriers to social engagement may have impeded the effectiveness of this intervention.

Topics in stroke rehabilitation · randomised controlled trial · 31 citationsread the source →

Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK.

Background: Remote digital health interventions to enhance physical activity provide a potential solution to improve the sedentary behaviour, physical inactivity, and poor health-related quality of life that are typical of chronic conditions, particularly for people with chronic kidney disease. However, there is a need for high-quality evidence to support implementation in clinical practice. The Kidney BEAM trial evaluated the clinical effect of a 12-week physical activity digital health intervention on health-related quality of life. Methods: In a single-blind, randomised controlled trial conducted at 11 centres in the UK, adult participants (aged ≥18 years) with chronic kidney disease were recruited and randomly assigned (1:1) to the Kidney BEAM physical activity digital health intervention or a waiting list control group. Randomisation was performed with a web-based system, in randomly permuted blocks of six. Outcome assessors were masked to treatment allocation. The primary outcome was the difference in the Kidney Disease Quality of Life Short Form version 1.3 Mental Component Summary (KDQoL-SF1.3 MCS) between baseline and 12 weeks. The trial was powered to detect a clinically meaningful difference of 3 arbitrary units (AU) in KDQoL-SF1.3 MCS. Outcomes were analysed by an intention-to-treat approach using an analysis of covariance model, with baseline measures and age as covariates. The trial was registered with ClinicalTrials.gov, NCT04872933. Findings: Between May 6, 2021, and Oct 30, 2022, 1102 individuals were assessed for eligibility, of whom 340 participants were enrolled and randomly assigned to the Kidney BEAM intervention group (n=173) or the waiting list control group (n=167). 268 participants completed the trial (112 in the Kidney BEAM group and 156 in the waiting list control group). All 340 randomly assigned participants were included in the intention-to treat population. At 12 weeks, there was a significant improvement in KDQoL-SF.13 MCS score in the Kidney BEAM group (from mean 44·6 AU [SD 10·8] at baseline to 47·0 AU [10·6] at 12 weeks) compared with the waiting list control group (from 46·1 AU [10·5] to 45·0 AU [10·1]; between-group difference of 3·1 AU [95% CI 1·8-4·4]; p<0·0001). Interpretation: The Kidney BEAM physical activity platform is an efficacious digital health intervention to improve mental health-related quality of life in patients with chronic kidney disease. These findings could facilitate the incorporation of remote digital health interventions into clinical practice and offer a potential intervention worthy of investigation in other chronic conditions. Funding: Kidney Research UK.

The Lancet. Digital health · randomised controlled trial · 48 citationsread the source →

Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study.

Background: Neurokinin 3 receptor antagonists are potential non-hormonal therapies for the treatment of vasomotor symptoms in menopausal women as options are scarce for those who cannot or do not want to take hormone therapy. Fezolinetant is one of the first non-hormonal neurokinin 3 receptor antagonists in development for the treatment of vasomotor symptoms due to menopause. This study investigated the safety and efficacy of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Methods: SKYLIGHT 1 is a randomised, double-blind, placebo-controlled, 12-week, phase 3 trial with a 40-week active treatment extension. This trial was done at 97 facilities across the USA, Canada, Czech Republic, Hungary, Poland, Spain, and the UK. Women aged 40-65 years with an average of seven or more moderate-to-severe hot flashes per day were randomly assigned (1:1:1) to once-daily exact-matched placebo, fezolinetant 30 mg, or fezolinetant 45 mg. Randomisation was done using a web-based interactive response system and investigators, project team members, clinical staff, and participants were masked to treatment assignment. Coprimary endpoints were mean change in frequency and severity of vasomotor symptoms from baseline to weeks 4 and 12. The efficacy and safety analyses comprised all randomly assigned participants who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov (NCT04003155) and is completed. Findings: Between July 11, 2019, and Aug 11, 2021, 2205 women were recruited of whom 175 were assigned to placebo, 176 to fezolinetant 30 mg, and 176 to fezolinetant 45 mg (175 in the placebo group, 174 in the fezolinetant 30 mg group, and 173 in the fezolinetant 45 mg received at least one dose [safety analysis set]). One participant randomly assigned to fezolinetant 45 mg received fezolinetant 30 mg in error, so the efficacy analysis set (full analysis set) consisted of 173 in the fezolinetant 30 mg group and 174 in the fezolinetant 45 mg group. 23 participants in the placebo group, 31 in the fezolinetant 30 mg group, and 13 in the fezolinetant 45 mg group discontinued treatment before week 12, mostly due to adverse events or participant withdrawal. Compared with placebo, fezolinetant 30 mg and fezolinetant 45 mg significantly reduced the frequency of vasomotor symptoms at week 4 (difference in change in least squares mean -1·87 [SE 0·42; p<0·001], -2·07 [SE 0·42; p<0·001]) and week 12 (-2·39 [SE 0·44; p<0·001], -2·55 [SE 0·43; p<0·001]). Compared with placebo, fezolinetant 30 mg and 45 mg significantly reduced the severity of vasomotor symptoms at week 4 (-0·15 [0·06; p=0·012], -0·19 [0·06; p=0·002]) and week 12 (-0·24 [0·08; p=0·002], -0·20 [0·08; p=0·007]). Improvements in frequency and severity of vasomotor symptoms were observed after 1 week and maintained over 52 weeks. During the first 12 weeks, treatment-emergent adverse events occurred in 65 (37%) of 174 women in the fezolinetant 30 mg group, 75 (43%) of 173 in the fezolinetant 45 mg group, and 78 (45%) of 175 in the placebo group. The incidence of liver enzyme elevations was low (placebo n=1; fezolinetant 30 mg n=2; fezolinetant 45 mg n=0) and these events were generally asymptomatic, transient, and resolved while on treatment or after treatment discontinuation. Interpretation: Data support the clinical use of fezolinetant as a non-hormonal treatment for vasomotor symptoms associated with menopause. The study was placebo-controlled for 12 weeks followed by a 40-week blinded extension to assess the maintenance of effect. Furthermore, the population studied was diverse and representative of the potential target population for fezolinetant therapy. Further characterisation of the benefit of fezolinetant on quality of life, including on symptoms of mood and sexual wellbeing, merits investigation. Funding: Astellas Pharma.

Lancet (London, England) · randomised controlled trial · 172 citationsread the source →

Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial.

Background: Obesity is associated with a reduction in life expectancy and an increase in mortality from cardiovascular diseases, cancer, and other causes. We therefore assessed the efficacy and safety of two doses of phentermine plus topiramate controlled-release combination as an adjunct to diet and lifestyle modification for weight loss and metabolic risk reduction in individuals who were overweight and obese, with two or more risk factors. Methods: In this 56-week phase 3 trial, we randomly assigned overweight or obese adults (aged 18-70 years), with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidaemia, diabetes or prediabetes, or abdominal obesity) to placebo, once-daily phentermine 7·5 mg plus topiramate 46·0 mg, or once-daily phentermine 15·0 mg plus topiramate 92·0 mg in a 2:1:2 ratio in 93 centres in the USA. Drugs were administered orally. Patients were randomly assigned by use of a computer-generated algorithm that was implemented through an interactive voice response system, and were stratified by sex and diabetic status. Investigators, patients, and study sponsors were masked to treatment. Primary endpoints were the percentage change in bodyweight and the proportion of patients achieving at least 5% weight loss. Analysis was by intention to treat. This study is registered with Clinical Trials.gov, number NCT00553787. Findings: Of 2487 patients, 994 were assigned to placebo, 498 to phentermine 7·5 mg plus topiramate 46·0 mg, and 995 to phentermine 15·0 mg plus topiramate 92·0 mg; 979, 488, and 981 patients, respectively, were analysed. At 56 weeks, change in bodyweight was -1·4 kg (least-squares mean -1·2%, 95% CI -1·8 to -0·7), -8·1 kg (-7·8%, -8·5 to -7·1; p<0·0001), and -10·2 kg (-9·8%, -10·4 to -9·3; p<0·0001) in the patients assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively. 204 (21%) patients achieved at least 5% weight loss with placebo, 303 (62%; odds ratio 6·3, 95% CI 4·9 to 8·0; p<0·0001) with phentermine 7·5 mg plus topiramate 46·0 mg, and 687 (70%; 9·0, 7·3 to 11·1; p<0·0001) with phentermine 15·0 mg plus topiramate 92·0 mg; for ≥10% weight loss, the corresponding numbers were 72 (7%), 182 (37%; 7·6, 5·6 to 10·2; p<0·0001), and 467 (48%; 11·7, 8·9 to 15·4; p<0·0001). The most common adverse events were dry mouth (24 [2%], 67 [13%], and 207 [21%] in the groups assigned to placebo, phentermine 7·5 mg plus topiramate 46·0 mg, and phentermine 15·0 mg plus topiramate 92·0 mg, respectively), paraesthesia (20 [2%], 68 [14%], and 204 [21%], respectively), constipation (59 [6%], 75 [15%], and 173 [17%], respectively), insomnia (47 [5%], 29 [6%], and 102 [10%], respectively), dizziness (31 [3%], 36 [7%], 99 [10%], respectively), and dysgeusia (11 [1%], 37 [7%], and 103 [10%], respectively). 38 (4%) patients assigned to placebo, 19 (4%) to phentermine 7·5 mg plus topiramate 46·0 mg, and 73 (7%) to phentermine 15·0 mg plus topiramate 92·0 mg had depression-related adverse events; and 28 (3%), 24 (5%), and 77 (8%), respectively, had anxiety-related adverse events. Interpretation: The combination of phentermine and topiramate, with office-based lifestyle interventions, might be a valuable treatment for obesity that can be provided by family doctors. Funding: Vivus.

Lancet (London, England) · randomised controlled trial · 667 citationsread the source →

The effectiveness of case-based learning in health professional education. A BEME systematic review: BEME Guide No. 23.

Background: Case-based learning (CBL) is a long established pedagogical method, which is defined in a number of ways depending on the discipline and type of 'case' employed. In health professional education, learning activities are commonly based on patient cases. Basic, social and clinical sciences are studied in relation to the case, are integrated with clinical presentations and conditions (including health and ill-health) and student learning is, therefore, associated with real-life situations. Although many claims are made for CBL as an effective learning and teaching method, very little evidence is quoted or generated to support these claims. We frame this review from the perspective of CBL as a type of inquiry-based learning. Aim: To explore, analyse and synthesise the evidence relating to the effectiveness of CBL as a means of achieving defined learning outcomes in health professional prequalification training programmes. Method: Selection criteria: We focused the review on CBL for prequalification health professional programmes including medicine, dentistry, veterinary science, nursing and midwifery, social care and the allied health professions (physiotherapy, occupational therapy, etc.). Papers were required to have outcome data on effectiveness. Search strategies: The search covered the period from 1965 to week 4 September 2010 and the following databases: ASSIA, CINAHL, EMBASE, Education Research, Medline and Web of Knowledge (WoK). Two members of the topic review group (TRG) independently reviewed the 173 abstracts retrieved from Medline and compared findings. As there was good agreement on inclusion, one went onto review the WoK and ASSIA EndNote databases and the other the Embase, CINAHL and Education Research databases to decide on papers to submit for coding. Coding and data analysis: The TRG modified the standard best evidence medical education coding sheet to fit our research questions and assessed each paper for quality. After a preliminary reliability exercise, each full paper was read and graded by one reviewer with the papers scoring 3-5 (of 5) for strength of findings being read by a second reviewer. A summary of each completed coding form was entered into an Excel spread sheet. The type of data in the papers was not amenable to traditional meta-analysis because of the variability in interventions, information given, student numbers (and lack of) and timings. We, therefore, adopted a narrative synthesis method to compare, contrast, synthesise and interpret the data, working within a framework of inquiry-based learning. Results: The final number of coded papers for inclusion was 104. The TRG agreed that 23 papers would be classified as of higher quality and significance (22%). There was a wide diversity in the type, timing, number and length of exposure to cases and how cases were defined. Medicine was the most commonly included profession. Numbers of students taking part in CBL varied from below 50 to over 1000. The shortest interventions were two hours, and one case, whereas the longest was CBL through a whole year. Group sizes ranged from students working alone to over 30, with the majority between 2 and 15 students per group. The majority of studies involved single cohorts of students (61%), with 29% comparing multiple groups, 8% involving different year groups and 2% with historical controls. The outcomes evaluation was either carried out postintervention only (78 papers; 75%), preintervention and postintervention (23 papers; 22%) or during and postintervention (3 papers; <3%). Our analysis provided the basis for discussion of definitions of CBL, methods used and advocated, topics and learning outcomes and whether CBL is effective based on the evaluation data. Conclusion: Overwhelmingly, students enjoy CBL and think that it enhances their learning. The empirical data taken as a whole are inconclusive as to the effects on learning compared with other types of activity. Teachers enjoy CBL, partly because it engages, and is perceived to motivate, students. CBL seems to foster learning in small groups though whether this is the case delivery or the group learning effect is unclear.

Medical teacher · systematic review · 534 citationsread the source →

A biobehavioral home-based intervention and the well-being of patients with dementia and their caregivers: the COPE randomized trial.

Context: Optimal treatment to postpone functional decline in patients with dementia is not established. Objective: To test a nonpharmacologic intervention realigning environmental demands with patient capabilities. Design, setting, and participants: Prospective 2-group randomized trial (Care of Persons with Dementia in their Environments [COPE]) involving patients with dementia and family caregivers (community-living dyads) recruited from March 2006 through June 2008 in Pennsylvania. Interventions: Up to 12 home or telephone contacts over 4 months by health professionals who assessed patient capabilities and deficits; obtained blood and urine samples; and trained families in home safety, simplifying tasks, and stress reduction. Control group caregivers received 3 telephone calls and educational materials. Main outcome measures: Functional dependence, quality of life, frequency of agitated behaviors, and engagement for patients and well-being, confidence using activities, and perceived benefits for caregivers at 4 months. Results: Of 284 dyads screened, 270 (95%) were eligible and 237 (88%) randomized. Data were collected from 209 dyads (88%) at 4 months and 173 (73%) at 9 months. At 4 months, compared with controls, COPE patients had less functional dependence (adjusted mean difference, 0.24; 95% CI, 0.03-0.44; P = .02; Cohen d = 0.21) and less dependence in instrumental activities of daily living (adjusted mean difference, 0.32; 95% CI, 0.09-0.55; P = .007; Cohen d = 0.43), measured by a 15-item scale modeled after the Functional Independence Measure; COPE patients also had improved engagement (adjusted mean difference, 0.12; 95% CI, 0.07-0.22; P = .03; Cohen d = 0.26), measured by a 5-item scale. COPE caregivers improved in their well-being (adjusted mean difference in Perceived Change Index, 0.22; 95% CI, 0.08-0.36; P = .002; Cohen d = 0.30) and confidence using activities (adjusted mean difference, 0.81; 95% CI, 0.30-1.32; P = .002; Cohen d = 0.54), measured by a 5-item scale. By 4 months, 64 COPE dyads (62.7%) vs 48 control group dyads (44.9%) eliminated 1 or more caregiver-identified problems (chi(2/1) = 6.72, P = . 01). Conclusion: Among community-living dyads, a nonpharmacologic biobehavioral environmental intervention compared with control resulted in better outcomes for COPE dyads at 4 months. Although no group differences were observed at 9 months for patients, COPE caregivers perceived greater benefits. Trial registration: clinicaltrials.gov Identifier: NCT00259454.

JAMA · randomised controlled trial · 235 citationsread the source →

Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial.

Background: Trazodone is a commonly prescribed off-label for sleep disturbance in alcohol-dependent patients, but its safety and efficacy for this indication is unknown. Methods: We conducted a randomized, double-blind, placebo-control trial of low-dose trazodone (50 to 150 mg at bedtime) for 12 weeks among 173 alcohol detoxification patients who reported current sleep disturbance on a validated measure of sleep quality or during prior periods of abstinence. Primary outcomes were the proportion of days abstinent and drinks per drinking day over 6-months; sleep quality was also assessed. Results: Urn randomization balanced baseline features among the 88 subjects who received trazodone and 85 who received placebo. The trazodone group experienced less improvement in the proportion of days abstinent during administration of study medication (mean change between baseline and 3 months: -0.12; 95% CI: -0.15 to -0.09), and an increase in the number of drinks per drinking day on cessation of the study medication (mean change between baseline and 6 months, 4.6; 95% CI: 2.1 to 7.1). Trazodone was associated with improved sleep quality during its administration (mean change on the Pittsburgh Sleep Quality Index between baseline and 3 months: -3.02; 95% CI: -3.38 to -2.67), but after it was stopped sleep quality equalized with placebo. Conclusions: Trazodone, despite a short-term benefit on sleep quality, might impede improvements in alcohol consumption in the postdetoxification period and lead to increased drinking when stopped. Until further studies have established benefits and safety, routine initiation of trazodone for sleep disturbance cannot be recommended with confidence during the period after detoxification from alcoholism.

Alcoholism, clinical and experimental research · randomised controlled trial · 73 citationsread the source →

The pleasure of art as a matter of fact

You have accessMoreSectionsView PDF ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InRedditEmail Cite this article Nadal Marcos and Skov Martin 2018The pleasure of art as a matter of factProc. R. Soc. B.2852017225220172252http://doi.org/10.1098/rspb.2017.2252SectionYou have accessCommentThe pleasure of art as a matter of fact Marcos Nadal Marcos Nadal http://orcid.org/0000-0002-9341-4688 Department of Psychology, University of the Balearic Islands, Palma de Mallorca 07122, Spain [email protected] Google Scholar Find this author on PubMed Search for more papers by this author and Martin Skov Martin Skov Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark Center for Decision Neuroscience, Copenhagen Business School, Copenhagen 2000, Denmark Google Scholar Find this author on PubMed Search for more papers by this author Marcos Nadal Marcos Nadal http://orcid.org/0000-0002-9341-4688 Department of Psychology, University of the Balearic Islands, Palma de Mallorca 07122, Spain [email protected] Google Scholar Find this author on PubMed and Martin Skov Martin Skov Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre, Copenhagen 2650, Denmark Center for Decision Neuroscience, Copenhagen Business School, Copenhagen 2000, Denmark Google Scholar Find this author on PubMed Published:21 March 2018https://doi.org/10.1098/rspb.2017.2252All other forms of perception divide a man, because they are exclusively based either on the sensuous or on the intellectual part of his being; only the perception of the Beautiful makes something whole of him, because both his natures must accord with it.— Schiller, 1793–1795, Letters on the Aesthetic Education of Man, p. 138, Letter 27Can art make us better people? Better members of society? In her recent article, 'Pleasure junkies all around! Why it matters and why "the arts" might be the answer: a biopsychological perspective', Christensen [1] claims that engaging with art can promote healthy choices, choices that balance short-term pleasure goals with long-term general well-being. She suggests that many modern life conveniences, such as social media, computer games or online shopping, have the potential to turn us into 'pleasure junkies' because they maximize short-term pleasures. But art, Christensen argues, is a safe choice and a means to remedy this unhealthy addiction to pleasure. Christensen's argument is grounded on three claims about the sort of pleasure we get from art. First, in contrast to low-level pleasure, which Christensen conceives as 'a mere perceptual stimulation leading to a rewarding sensation (food, sex, etc.)' ([1], p. 2), pleasure from art is presented as a kind of higher-order pleasure that engages 'broader neural networks implied in the attribution of meaning' (p. 2), presumably leading to 'long-term maintenance of healthy bodily function' (p. 2). Second, 'the arts do not induce states of craving without fulfilment—as do activities with reinforcement schedules which are prone to create habits and addictions such as intermittent variable ratio or interval reinforcement schedules (e.g. social media, gambling, football, extreme sports, drugs' (p. 4). Third, 'the arts do not search for a perceptual "Bliss point" […]. They do not just repeat over and over again a sensory stimulus that excites the senses and induces craving for more of a "pleasurable itch" (e.g. sugar, sexualized body displays, certain musical lyrics, tones; i.e. a perceptual "bliss point")' (p. 4).The claim, in a nutshell, is that the pleasure induced by art is different to the pleasure induced by food, sex, sports or drugs, because it is related to the balanced activation of brain systems related to short-term pleasure and long-term wellbeing goals, because it does not induce craving, and because it is not aimed at a perceptual 'bliss point'. This distinct sort of pleasure, according to Christensen, makes it possible for the arts to thwart the pernicious effects that the unhealthy urges and cravings licensed by 'today's mainstream acceptance of pleasure-seeking behaviour' (p. 5) have on individuals' lives and on societies. Such sweeping statements about art, food, sex, sports and society as a whole merit close examination. Christensen's primary claim that the pleasure induced by art is of a special kind, different to the pleasure induced by other activities is not supported by current understanding of what pleasure is. It is, moreover, contradicted by abundant empirical evidence. This evidence shows that pleasures, whatever their source, owe to activity in the same mesocorticolimbic circuit [2] and are encoded as a common neural currency [3]. As Kent Berridge and Morten Kringelbach put it: 'the brain mechanisms involved in fundamental pleasures (food and sexual pleasures) overlap with those for higher-order pleasures (e.g. monetary, artistic, musical, altruistic and transcendent pleasures) […] From sensory pleasures and drugs of abuse […] to monetary, aesthetic and musical delights, all pleasures seem to involve the same hedonic brain systems' ([4], p. 481). Thus, there is no evidence for specific brain regions or neural circuits related to the pleasure from art. Rather, the appreciation of art relies on brain mechanisms that evolved to appraise the value of biologically relevant objects in relation to internal homeostatic states [5]: 'Emotional reactions to music, further, activate the same cortical, subcortical and autonomic circuits, which are considered as the essential survival circuits of biological organisms in general' ([6], p. 6). In sum, the evidence shows that pleasure elicited by music and other art forms is no different in genesis and function to the pleasure induced by food, drugs and sex [7,8]. This is a matter of fact, not opinion. What supports Christensen's argument if not empirical evidence? In our view, her argument for the distinctness of art-induced pleasure seems based upon an oversimplified and devaluing conception of the pleasures of sex, food and sports, and a very narrow notion of art and its function. Christensen presents food, sex and sports as meaningless low-level sources of pleasure, and the arts as privileged vehicles for meaningful experiences. It is the personal and meaningful engagement with art—Christensen suggests—that fosters a balanced activation of brain systems related to short-term pleasure and long-term well-being goals. However, rarely—if ever—are food, sex and sports meaningless rewarding sensations. Contrary to Christensen's definition on page 2 of her article, pleasure—even sensory pleasure—is not simply reward, and never simply a sensation [4]. Indulging in food, sex or sports are meaningful and personally significant experiences that are not a matter of mere physical sensation. The experience of pleasure from food and sex is shaped by context, knowledge, expectations, anticipations, attitudes and beliefs that bring meaning to them [9–11]. Sex can be meaningful because it signifies physical connection with one's loved one, because it is cheating on someone, or deemed a sin. Likewise, eating is not about obtaining low-level pleasure. What we eat, the way we eat, what we believe about what we eat, where and whom we eat with, imbue eating with individual and social meaning, and shape the actual pleasure of eating [12]. On the other hand, encounters with art are not necessarily meaningful [13,14]. Actually, there is nothing intrinsically meaningful about engaging with art. Many laypeople lack the knowledge schemata required to engage meaningfully with abstract, cubist or contemporary art [15,16]. There are plenty of artworks people do not find meaningful or pleasant. Meaning making is not a special feature of art; it is a general feature of our species's cognition [17,18]. We can endow virtually any aspect of reality with meaning: sex, food, sports, a urinal, the shape of a cloud, an averted glance, someone's absence. Christensen's argument also rests on a historically and culturally narrow conception of art and its function. Art is presented as a circumscribed category of activities that elicit a unique sort of pleasant experiences: — The arts are set of activities of a special kind that share certain defining features distinguishing them from other activities: 'the arts push boundaries, surprise, reveal and excite both artist and spectator' ([1], p. 4).— Art encounters are positive, leading to 'pleasurable chills' and pleasurable experiences of understanding: 'The moment of meaning-assignation, also called "mastering" or "understanding" an artwork, is therefore a pleasurable experience' ([1], p. 4).— The pleasure elicited by art is special, because it does not involve craving for intense peaks: 'The arts do not search for a perceptual "bliss point" […] They do not just repeat over and over a sensory stimulus that excites the senses and induces craving for more of a "pleasurable itch"' ([1], p. 4).This characterization of the arts substantially overlaps with the notion of 'fine arts'. The core features of this characterization were instituted in the eighteenth century, after European intellectuals grouped certain activities into a distinct and autonomous collection, labelled 'fine arts'. To make sense of and promote this grouping, it became imperative to identify a common essence setting art apart from other activities [19,20,21]. One of the most popular proposals was that only art could produce a special sort of pleasure, sophisticated and polite [19,21]—a conception stemming not from any understanding of physiology, but from mere speculation. This limited historical and cultural scope renders this conception of the arts unfit for behavioural or neuroscientific research [19]. The category 'the arts' should not be mistaken for a natural kind. It is a historical convention, and has no direct biological correspondence. Moreover, this conception of art that Christensen espouses does not apply to art as practised in non-Western societies [19,22]. It does not even apply to Western art before the eighteenth century or after the nineteenth century [19,20,21]. First, art does not necessarily evoke pleasurable experiences. There are abundant artworks intended to arouse negative emotions [19,23], and to portray physical and moral ugliness [24]. Understanding art is not necessarily a pleasant experience: it can be an angering, disgusting or upsetting one [25]. Second, many artworks actually exploit repetition, bliss points and craving [26]. Repetition is a fundamental design feature of music and other performance arts [27]: In Relation in Space (1976) Marina Abramovic and Ulay ran into each other repeatedly for an hour; Ravel's Bolero is a 17 min-long instance of melodic and rhythmic repetitiveness. Anticipation and craving for bliss points are also essential to music [28]. In fact, the enjoyment of music is linked to intense feelings of anticipation and expectation caused by dopamine activity in the caudate nucleus (also involved in the rewarding aspect of food) [29,30], and peak pleasure states (bliss points) [31], caused by the release of dopamine and opioids in the brain's reward system (also involved in cocaine induced euphoria) [29,30]. Given the available evidence, therefore, there is no reason to believe that the pleasure from art is special or unique [32].In sum, Christensen's claim for the distinctiveness of pleasure from art is contradicted by empirical evidence, and her argument for the beneficial effects of art rests upon disputed foundations. Art's capacity to promote healthier choices and make us better people that can contribute to a better society remains as unconfirmed today as it was when Schiller speculated on art's power to harmonize human's conflicting sensuous and formal impulses. Christensen's argument is problematic even if intended to highlight hypothetical possibilities. Arguments about hypothetical possibilities should still rely on valid premises, and scientific hypotheses should be grounded on evidence, or at least in line with it. Otherwise, they are merely unfounded speculations. Scientific aesthetics is only just finding its footing and its place within cognitive neuroscience [33,34]. If evidence is ignored or rejected because it does not fit preconceived notions about art and its function, scientific aesthetics will become only an arena to promote and legitimize personally appealing notions of art by applying a scientific gloss over them. A proper scientific study of art needs to be grounded on empirical evidence and strong arguments that follow from solid premises [35,36]. Only then can scientific aesthetics provide reliable explanations for artistic and aesthetic behaviour, and thus make a significant contribution to the understanding of our human nature. Data accessibilityThis article has no additional data. Authors' contributionsBoth authors have contributed to conceiving, developing and writing the research presented in this paper, and approved it for publication. Competing interestsWe declare we have no competing interests. FundingThis research was supported by grant PSI2016-77327-P (MINECO/AEI/ERDF, EU).Footnotes© 2018 The Author(s)Published by the Royal Society. All rights reserved. References1Christensen JF. 2017Pleasure junkies all around! Why it matters and why 'the arts' might be the answer: a biopsychological perspective. Proc. R. Soc. B 284, 20162837. (doi:10.1098/rspb.2016.2837) Link, ISI, Google Scholar2Berridge CW, Kringelbach ML. 2013Neuroscience of affect: brain mechanisms of pleasure and displeasure. Curr. Opin. 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(doi:10.1016/j.plrev.2017.06.013) PubMed, ISI, Google Scholar Previous ArticleNext Article VIEW FULL TEXT DOWNLOAD PDF FiguresRelatedReferencesDetailsCited by Clemente A, Pearce M, Skov M and Nadal M (2021) Evaluative judgment across domains: Liking balance, contour, symmetry and complexity in melodies and visual designs, Brain and Cognition, 10.1016/j.bandc.2021.105729, 151, (105729), Online publication date: 1-Jul-2021. Chuan-Peng H, Huang Y, Eickhoff S, Peng K and Sui J (2020) Seeking the "Beauty Center" in the Brain: A Meta-Analysis of fMRI Studies of Beautiful Human Faces and Visual Art, Cognitive, Affective, & Behavioral Neuroscience, 10.3758/s13415-020-00827-z, 20:6, (1200-1215), Online publication date: 1-Dec-2020. Skov M and Nadal M (2020) A Farewell to Art: Aesthetics as a Topic in Psychology and Neuroscience, Perspectives on Psychological Science, 10.1177/1745691619897963, 15:3, (630-642), Online publication date: 1-May-2020. Kalpokas I (2019) Making the Theory Political A Political Theory of Post-Truth, 10.1007/978-3-319-97713-3_4, (87-121), . Kalpokas I (2019) Affective Encounters of the Algorithmic Kind: Post-Truth and Posthuman Pleasure, Social Media + Society, 10.1177/2056305119845678, 5:2, (205630511984567), Online publication date: 1-Apr-2019. Skov M (2019) Aesthetic Appreciation: The View From Neuroimaging, Empirical Studies of the Arts, 10.1177/0276237419839257, 37:2, Online publication date: H, I and (2020) A for We Aesthetic in Human Neuroscience, A and in A New for Arts, This March Article in 2018 The Author(s)Published by the Royal Society. All rights Citations and are available with

Proceedings of the Royal Society B Biological Sciences · editorial or comment · 24 citationsread the source →

After surgery: the effects of life-saving caesarean sections in Burkina Faso.

Background: In African countries, caesarean sections are usually performed to save mothers and babies' lives, sometimes in extremis and at considerable costs. Little is known about the health and lives of women once discharged after such surgery. We investigated the long-term effects of life-saving caesarean section on health, economic and social outcomes in Burkina Faso. Methods: We conducted a 4 year prospective cohort study of women and their babies using mixed methods. The quantitative sample was selected in seven hospitals and included 950 women: 100 women with a caesarean section associated with near-miss complication (life-saving caesareans); 173 women with a vaginal birth associated with near-miss complication; and 677 women with uncomplicated vaginal childbirth. Structured interviews were conducted at 3 months, 6 months, 12 months and 3 and 4 years postpartum. These were supplemented by medical record data on delivery and physical examinations at 6 and 12 months postpartum. The lives and experiences of 21 women were documented ethnographically. Data were analysed with multivariable logistic regressions, using survival analysis and thematic analysis. Results: The physical effects of life-saving caesareans appeared to be similar to women who had an uncomplicated childbirth, although 55% of women with life-saving caesareans had another caesarean in their next pregnancy. The negative effects were generally economic, social and reproductive when compared to vaginal births, including increased debts (AOR = 3.91 (1.46-10.48) and sexual violence (AOR = 4.71 (1.04-21.3)) and lower fertility (AOR = 0.44 (0.24-0.80)) 4 years after life-saving caesareans. In the short and medium term, women with life-saving caesareans appeared to suffer increased psychological distress compared to uncomplicated births. They were more likely to use contraceptives (AOR = 5.95 (1.53-23.06); 3 months). Mortality of the index child was increased in both near-miss groups, independent of delivery mode. Ethnographic data suggest that these consequences are significant for Burkinabe women, whose well-being and social standing are mostly determined by their fertility, marriage strength and family links. Conclusions: Life-saving caesareans have broad consequences beyond clinical sequelae. The recent policy to subsidise emergency obstetric care costs implemented in Burkina Faso should help avoid the majority of catastrophic costs, shown to be problematic for women undergoing emergency caesarean section.

BMC pregnancy and childbirth · 19 citationsread the source →

The Leveraging Exercise to Age in Place (LEAP) Study: Engaging Older Adults in Community-Based Exercise Classes to Impact Loneliness and Social Isolation.

Objective: Social isolation and loneliness are associated with morbidity and mortality in older adults. Limited evidence exists regarding which interventions improve connectedness in this population. Design/setting/participants: In this pre-post study we assessed community-based group health class participants' (age ≥50) loneliness and social isolation. Participants (n = 382) were referred by a Cedars-Sinai Medical Network (Los Angeles, California) healthcare provider or self-referred from the community (July 2017-March 2020). Intervention: Participants met with a program coordinator and selected Arthritis Exercise, Tai Chi for Arthritis, EnhanceFitness, or the Healthier Living Workshop. Measurements: We measured social isolation using the Duke Social Support Index (DSSI) and loneliness using the UCLA 3-item Loneliness Scale at baseline, class completion, and 6 months. Results: Mean age was 76.8 years (standard deviation, SD = 9.1); 315 (83.1%) were female; 173 (45.9%) were Non-Hispanic white; 143 (37.9%) were Non-Hispanic Black; 173 (46.1%) lived alone; mean baseline DSSI score was 26.9 (SD = 4.0) and mean baseline UCLA score was 4.8 (SD = 1.8). On multivariable analysis adjusted for gender, race/ethnicity, income, self-rated health, and household size, DSSI improved by 2.4% at 6-week compared to baseline (estimated ratio, ER: 1.024; 95% confidence interval [CI]: 1.010-1.038; p-value = 0.001), and 3.3% at 6-month (ER: 1.033; 95% CI: 1.016-1.050; p-value <0.001). UCLA score after adjusting for age, gender, race/ethnicity, live alone, number of chronic conditions, income, and self-rated health, did not change at 6-week (ER: 0.994; 95% CI: 0.962-1.027; p-value = 0.713), but decreased by 6.9% at 6-months (ER: 0.931; 95% CI: 0.895-0.968; p-value <0.001). Conclusion: Community-based group health class participants reported decreased loneliness and social isolation at 6-month follow-up.

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 38 citationsread the source →

Sensing the body matters: profiles of interoceptive sensibility in chronic pain adjustment.

Interoception is critical to health regulation and is often disrupted in individuals with chronic pain (ICPs). Interoceptive sensibility (IS)-the self-reported experience and relationship toward internal states-includes skills such as sensing, interpreting, and using bodily information for self-regulation. Current studies on IS and chronic pain (CP) adjustment are scarce, and how the interplay between different IS skills shapes CP adjustment remains unclear. This cross-sectional study aimed to identify profiles of IS skills among ICPs and examined their associations with pain outcomes and psychological and behavioral risk or protective processes. Individuals with chronic musculoskeletal pain (n = 173; 84.4% women) completed the Multidimensional Assessment of Interoceptive Awareness (MAIA), measures of CP adjustment (depression, anxiety, vitality, pain severity, interference, and physical function), psychological (self-efficacy, catastrophizing, and kinesiophobia), and behavioral processes (activity patterns). A cluster analysis identified 3 IS skills profiles: (1) high IS skills (n = 68), with the highest levels of attention regulation toward bodily sensations, body trust, listening for insight, and self-regulation; (2) low IS skills (n = 29), who distracted less and worried more about bodily sensations, and presented lower-body trust; and (3) mixed IS skills (n = 71), despite good body trust, attention regulation, and low worrying, showed lower awareness of body-mind connections. Interoceptive sensibility skills profiles differed in depression, vitality (fatigue), and psychological or behavioral processes, such as pain-related self-efficacy, catastrophizing, kinesiophobia, and activity pacing. These findings contribute to integrating body-mind connections more explicitly into current theoretical CP models and developing tailored interventions targeting specific IS skills to improve CP adjustment.

Pain · 10 citationsread the source →

Toward an optimized measure of perceived partner responsiveness: Development and validation of the perceived responsiveness and insensitivity scale.

Perceived partner responsiveness (PPR; Reis & Shaver, Handbook of personal relationships, 1988, Wiley)-the belief that one's partner will attend to core concerns-is a construct in basic relationship research that can help evaluate intimacy in couple therapy. However, research into PPR is hampered by a lack of standardized measurement. Three studies were undertaken to develop and evaluate an optimized self-report PPR measure. In Study 1, n = 2,334 respondents completed 246 candidate items derived from 19 PPR measures. Exploratory factor analyses identified two underlying dimensions, Responsiveness and Insensitivity. Item response theory was used to develop two 8-item subscales for the Perceived Responsiveness and Insensitivity scale (PRI), both of which showed incremental prediction over global satisfaction. In Study 2, n = 173 respondents completed the brief PRI along with measures of global relationship evaluations and concrete relationship behaviors every other week for 8 weeks. Random intercept cross-lagged panel models found the PRI subscales were more sensitive than global evaluations to fluctuations in support and conflict. In Study 3, n = 161 heterosexual couples completed the brief PRI along with self-reports of responsive and insensitive behaviors. Actor-partner interdependence models demonstrated the PRI subscales were associated with partners' self-reported behaviors even after controlling for own behaviors. Thus, the PRI offers a PPR measure that demonstrates desirable properties for treatment research including (a) incremental validity over global satisfaction, (b) ability to detect meaningful change over time, and (c) sensitivity to partners' behaviors in the relationship. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Psychological assessment · 24 citationsread the source →

Timely Digital Patient-Clinician Communication in Specialist Clinical Services for Young People: A Mixed-Methods Study (The LYNC Study).

Background: Young people (aged 16-24 years) with long-term health conditions can disengage from health services, resulting in poor health outcomes, but clinicians in the UK National Health Service (NHS) are using digital communication to try to improve engagement. Evidence of effectiveness of this digital communication is equivocal. There are gaps in evidence as to how it might work, its cost, and ethical and safety issues. Objective: Our objective was to understand how the use of digital communication between young people with long-term conditions and their NHS specialist clinicians changes engagement of the young people with their health care; and to identify costs and necessary safeguards. Methods: We conducted mixed-methods case studies of 20 NHS specialist clinical teams from across England and Wales and their practice providing care for 13 different long-term physical or mental health conditions. We observed 79 clinical team members and interviewed 165 young people aged 16-24 years with a long-term health condition recruited via case study clinical teams, 173 clinical team members, and 16 information governance specialists from study NHS Trusts. We conducted a thematic analysis of how digital communication works, and analyzed ethics, safety and governance, and annual direct costs. Results: Young people and their clinical teams variously used mobile phone calls, text messages, email, and voice over Internet protocol. Length of clinician use of digital communication varied from 1 to 13 years in 17 case studies, and was being considered in 3. Digital communication enables timely access for young people to the right clinician at the time when it can make a difference to how they manage their health condition. This is valued as an addition to traditional clinic appointments and can engage those otherwise disengaged, particularly at times of change for young people. It can enhance patient autonomy, empowerment and activation. It challenges the nature and boundaries of therapeutic relationships but can improve trust. The clinical teams studied had not themselves formally evaluated the impact of their intervention. Staff time is the main cost driver, but offsetting savings are likely elsewhere in the health service. Risks include increased dependence on clinicians, inadvertent disclosure of confidential information, and communication failures, which are mostly mitigated by young people and clinicians using common-sense approaches. Conclusions: As NHS policy prompts more widespread use of digital communication to improve the health care experience, our findings suggest that benefit is most likely, and harms are mitigated, when digital communication is used with patients who already have a relationship of trust with the clinical team, and where there is identifiable need for patients to have flexible access, such as when transitioning between services, treatments, or lived context. Clinical teams need a proactive approach to ethics, governance, and patient safety.

Journal of medical Internet research · 41 citationsread the source →

Interparental conflict, negative parenting, and children's adjustment: bridging links between parents' depression and children's psychological distress.

Pathways linking parental depressive symptoms, adult relationship insecurity, interparental conflict, negative parenting, and children's psychological adjustment (internalizing symptoms and externalizing problems) were assessed using a 3-wave longitudinal research design. Two-parent families (N = 352) with 11- to 13-year-old children (179 boys, 173 girls) participated in the study. Maternal and paternal depressive symptoms were associated with insecurity in adult close relationships assessed 12 months later, which was concurrently related to heightened levels of interparental conflict. Controlling for children's initial symptom levels, interparental conflict was related to child appraisals of father and mother rejection assessed an additional 12 months later, which were related to children's internalizing symptoms and externalizing problems, respectively. Results are discussed with regard to the implications for understanding the complex interplay between adult depressive symptoms, attributions in close adult relationships, interparental conflict, negative parenting, and children's psychological adjustment.

Journal of family psychology : JFP : journal of the Division of Family Psychology of the American Psychological Association (Division 43) · 78 citationsread the source →

Long chain omega-3 fatty acids intake, fish consumption and mental disorders in the SUN cohort study.

Background: Very long chain omega-3 fatty acids (w-3 PUFA) intake and fish consumption have been suggested as protective factors against neuropsychiatric disorders but there is scarcity of large cohort studies assessing this association. Aim of the study: To assess the association between w-3-PUFA intake and fish consumption and mental disorders. Methods: A prospective cohort study was performed in 7,903 participants. W-3 PUFA intake and fish consumption were ascertained through a validated semi-quantitative food frequency questionnaire. The outcomes after 2 years of follow-up were: (1) Incident mental disorder (depression, anxiety, or stress), (2) incident depression, and (3) incident anxiety. Logistic regression models and generalized additive models were fit to assess the relationship between w-3 PUFA intake or fish consumption and the incidence of these outcomes. Odds ratios (OR) and their 95% confidence intervals (CI) were calculated. Results: 173 cases of depression, 335 cases of anxiety, and 4 cases of stress were observed during 2-year follow-up. ORs (95% CI) of mental disorder for successive quintiles of energy-adjusted w-3 PUFA intake were 1 (reference), 0.72 (0.52-0.99), 0.79 (0.58-1.08), 0.65 (0.47-0.90), and 1.04 (0.78-1.40). Subjects with a moderate consumption of fish (third and fourth quintiles of consumption: median of each quintile 83.3 and 112 g/day, respectively) had a relative risk reduction higher than 30%. Conclusions: A potential benefit of w-3 PUFA intake on total mental disorders is suggested, although no linear trend was apparent.

European journal of nutrition · 117 citationsread the source →

Associations between HIV-related stigma, racial discrimination, gender discrimination, and depression among HIV-positive African, Caribbean, and Black women in Ontario, Canada.

African, Caribbean, and Black (ACB) women are greatly overrepresented in new HIV infections in comparison with Canada's general population. Social and structural factors such as HIV-related stigma, gender discrimination, and racial discrimination converge to increase vulnerability to HIV infection among ACB women by reducing access to HIV prevention services. Stigma and discrimination also present barriers to treatment, care, and support and may contribute to mental health problems. We administered a cross-sectional survey to HIV-positive ACB women (n=173) across Ontario in order to examine the relationships between HIV-related stigma, gender discrimination, racial discrimination, and depression. One-third of participants reported moderate/severe depression scores using the Beck Depression Inventory Fast-Screen guidelines. Hierarchical block regression, moderation, and mediation analyses were conducted to measure associations between independent (HIV-related stigma, gender discrimination, racial discrimination), moderator/mediator (social support, resilient coping), and dependent (depression) variables. Findings included: (1) HIV-related stigma was associated with increased depression; (2) resilient coping was associated with reduced depression but did not moderate the influence of HIV-related stigma on depression; and (3) the effects of HIV-related stigma on depression were partially mediated through resilient coping. HIV-related stigma, gender discrimination, and racial discrimination were significantly correlated with one another and with depression, highlighting the salience of examining multiple intersecting forms of stigma. Generalizability of findings may be limited due to nonrandom sampling. Findings emphasize the importance of multi-component interventions, including building resilient coping skills, mental health promotion and assessment, and stigma reduction programs.

AIDS patient care and STDs · 158 citationsread the source →